{"entity":{"id":"durvalumab","kind":"drug","name":"Durvalumab","aka":[],"tldr":"A PD-L1 blocker that became standard after chemoradiation for stage III lung cancer, and now in bladder, biliary, and gastric cancers.","summary":"PACIFIC (unresectable stage III NSCLC), ADRIATIC (limited-stage SCLC, 2024), TOPAZ-1 (biliary tract), HIMALAYA (HCC with tremelimumab), NIAGARA (perioperative muscle-invasive bladder cancer, 2025), MATTERHORN (perioperative gastric, 2025), and Q2 2026 high-risk non-muscle-invasive bladder cancer with BCG (POTOMAC). Partner of Dato-DXd in TROPION-Breast05.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Durvalumab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Durvalumab"},{"label":"NICE TA798: durvalumab for maintenance treatment of unresectable non-small-cell lung cancer after platinum-based chemoradiation","url":"https://www.nice.org.uk/guidance/ta798"},{"label":"NICE TA1030: durvalumab with chemotherapy before surgery then alone after surgery for resectable non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1030"},{"label":"NICE TA1041: durvalumab with etoposide and either carboplatin or cisplatin for untreated extensive-stage small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta1041"},{"label":"NICE TA1099: durvalumab for treating limited-stage small-cell lung cancer after platinum-based chemoradiotherapy","url":"https://www.nice.org.uk/guidance/ta1099"}],"tags":[],"related":[],"cancers":["nsclc","sclc","cholangiocarcinoma","intrahepatic-cholangiocarcinoma","extrahepatic-cholangiocarcinoma","hcc","hcc-advanced","hcc-intermediate","urothelial","gastric","tnbc","resectable-nsclc","stage-iii-unresectable-nsclc","limited-stage-sclc","extensive-stage-sclc","advanced-recurrent-endometrial-cancer","tnbc-early","tnbc-metastatic","lung-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pdl1"],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":["tropion-breast05","nct05170204","nct07005128","nct03800134","nct05043090","nct07361497","nct06746116","nct03164616","nct05883644","nct03847428","nct05557838","nct07195695","nct07081633","nct06780137","nct03228667","nct05925530","nct04745689","nct06606847","nct04644289","nct06463665","nct04068610","nct03775486","nct05061550","nct05063565","nct05733598","nct07459634","nct06040099","nct07174583","nct05061134","nct03944772","nct02519348","nct05742607","nct07720284","nct03706690","nct07710885","nct05771480","nct03682068","nct05498155","nct06008093","nct05687266","nct04538742","nct06467357","nct02671435","nct02516241","nct05943106","nct06667908","nct02453282","nct06960577","nct03837899","nct02542293","nct06112379","nct03833154","nct04999969","nct04379596","nct03003962","nct05374603","nct06992609","nct03459846","nct03742102","nct07221253","nct06591520","nct04960709","nct05941897","nct04550260","nct06890598","phoenix","diamond","tropion-breast03","pacific","pacific-2","caspian","adriatic","gemstone-301"],"people":["lajos-pusztai"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Imfinzi","modality":"Monoclonal antibody (anti-PD-L1)","mechanism":"Human IgG1 anti-PD-L1 with reduced Fc effector function.","approvals":[{"region":"US","year":2017,"indication":"Locally advanced or metastatic urothelial carcinoma after platinum (accelerated; indication withdrawn 2021)"},{"region":"US","year":2018,"indication":"Unresectable stage III NSCLC after chemoradiation"},{"region":"US","year":2022,"indication":"Locally advanced or metastatic biliary tract cancer (gallbladder cancer included) with gemcitabine and cisplatin (TOPAZ-1)","note":"Imfinzi label section 1.3 (openFDA): https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22IMFINZI%22"},{"region":"UK","year":2024,"indication":"Locally advanced, unresectable or metastatic biliary tract cancer with gemcitabine and cisplatin; NICE TA944 recommended 10 January 2024 with a commercial arrangement","note":"https://www.nice.org.uk/guidance/ta944"},{"region":"US","year":2026,"indication":"High-risk NMIBC with BCG"},{"region":"England (NICE)","year":2022,"indication":"Locally advanced unresectable non-small-cell lung cancer with PD-L1 on 1 percent or more of cells that has not progressed after concurrent platinum-based chemoradiation","note":"TA798, published 22 June 2022 (PACIFIC). The PD-L1 restriction and the requirement for concurrent, not sequential, chemoradiation are NICE conditions the licence does not carry."},{"region":"England (NICE)","year":2025,"indication":"Untreated extensive-stage small-cell lung cancer, with etoposide and either carboplatin or cisplatin","note":"TA1041, published 19 February 2025, only at ECOG performance status 0 or 1 (CASPIAN)."},{"region":"England (NICE)","year":2025,"indication":"Resectable non-small-cell lung cancer (4 cm or more, or node positive) without an EGFR mutation or ALK rearrangement, neoadjuvant with platinum chemotherapy then adjuvant alone","note":"TA1030, published 15 January 2025 (AEGEAN)."},{"region":"England (NICE)","year":2025,"indication":"Limited-stage small-cell lung cancer that has not progressed after platinum-based chemoradiotherapy","note":"TA1099, published 1 October 2025 (ADRIATIC); must be funded in England within 90 days of publication."}],"mechanismSteps":["Antibody binds PD-L1","PD-1/PD-L1 engagement between T cell and tumour is blocked","Exhausted tumour-reactive T cells regain effector function","Interferon-γ and cytotoxic granules are released at the tumour","Tumour cells are killed; memory T cells persist"],"dosing":{"route":"IV infusion","schedule":"10 mg/kg every 2 weeks or 1,500 mg every 4 weeks (≥30 kg); up to 12 months after chemoradiation in stage III NSCLC","modifications":"Hold for grade 2 pneumonitis; discontinue for grade 3-4","monitoring":"Respiratory symptoms after chemoradiation, thyroid, LFTs, creatinine","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3"},"toxicity":[{"event":"Pneumonitis (any cause, PACIFIC)","anyGradePct":18.3,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"vs 12.8% placebo; 1.1% fatal"},{"event":"Cough","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"PACIFIC; all-grade ≥20%"},{"event":"Fatigue","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"PACIFIC; all-grade ≥20%"},{"event":"Radiation pneumonitis","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"PACIFIC; all-grade ≥20%"},{"event":"Upper respiratory infection","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"PACIFIC; all-grade ≥20%"},{"event":"Dyspnoea","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"PACIFIC; all-grade ≥20%"},{"event":"Rash","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8baba4ea-2855-42fa-9bd9-5a7548d4cec3","note":"PACIFIC; all-grade ≥20%"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.astrazeneca-us.com/medicines/access-360","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended after chemoradiation in stage III NSCLC (TA798), biliary tract cancer, limited-stage SCLC, perioperative bladder and gastric cancer","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2017-05-01","type":"accelerated-approval","region":"US","note":"Urothelial carcinoma (accelerated; later withdrawn 2021)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Locally advanced or metastatic urothelial carcinoma that progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy"},{"date":"2018-02-16","type":"approval","region":"US","note":"Unresectable stage III NSCLC after chemoradiation (PACIFIC)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2020-03-27","type":"approval","region":"US","note":"Extensive-stage SCLC with chemotherapy (CASPIAN)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2021-02-19","type":"withdrawal","region":"US","note":"Withdrawn: the indication came off the label 3.8 years after its accelerated approval.","indication":"Locally advanced or metastatic urothelial carcinoma that progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy"},{"date":"2022-09-02","type":"approval","region":"US","note":"Biliary tract cancer with chemotherapy (TOPAZ-1)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2022-10-21","type":"approval","region":"US","note":"HCC with tremelimumab (HIMALAYA)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2024-12-04","type":"approval","region":"US","note":"Limited-stage SCLC after chemoradiation (ADRIATIC)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2025-03-28","type":"approval","region":"US","note":"Perioperative muscle-invasive bladder cancer 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